Kornimate/medical-research-clean huggingface dataset:
an allergen biocube (abc) study evaluating the efficacy of fluticasone propionate nasal spray compared to placebo

Conditions: Allergic Rhinitis; Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the onset of action of fluticasone propionate nasal spray compared to placebo nasal spray in reducing nasal allergic signs and symptoms following ragweed exposure in the allergen biocube (abc) after up to 14 days of at home dosing.


Eligibility criteria:
inclusion criteria: * provide written informed consent and signed hipaa form; * be able and willing to follow all instructions and attend the study visits; * if female and of childbearing potential, be not pregnant, nursing or planning a pregnancy, be willing to submit a pregnancy test at visit 1 and at exit visit, and to use adequate method of birth control * have a positive history of seasonal allergic rhinitis to ragweed; * have a positive skin test reaction to ragweed of within the past 24 months; * manifest sufficient allergic rhinitis symptoms during ragweed exposure in the abc exclusion criteria: * known intolerance or allergy to antihistamines or corticosteroids; * have a compromised lung function at visit 1; * develop a compromised lung function at visits 2-6 * have any presence of active sinus or nasal infection at any visit; * have experienced an acute upper or lower respiratory tract infection or acute sinusitis within 30 days of visit 1; * have significant nasal anatomical deformities or any condition that does not allow subject to breathe through the nose (includes, but is not limited to: septal deviation, septal perforations, nasal polyps, rhinitis medicamentosa) * have had any nasal surgical intervention in the past; * have a known history of glaucoma * have planned surgery (nasal, ocular or systemic) during the trial period or within 30 days thereafter; * inability or refusal to discontinue contact lens wear during all visits; * use disallowed medications during the study or appropriate pre-study washout period
study of comparing of with and without sequential therapy of s-1

Conditions: Locally Advanced Gastric Adenocarcinoma; Chemotherapy Effect

Summary: the goal of this single arm clinical trial is to learn about sequential s-1 adjuvant therapy in patient wich locally advanced gastric cancer. the main question it aims to answer is: • the efficacy and safety of s-1 adjuvant therapy, following d2 radical surgery and ds(docetaxel + s-1) adjuvant chemotherapy. all patients with locally advanced gastric cancer will received d2 radical surgery, 6 cycles of ds chemotherapy, and sequential s-1 chemotherapy up to 1 year postoperation.


Eligibility criteria:
inclusion criteria: * (1) histologically or cytologically confirmed adenocarcinoma of the stomach or adenocarcinoma of the gastroesophageal junction; * (2) radical surgery (d2 lymph node dissection) for gastric cancer in our center, with postoperative pathological stage of stage iii; * (3) no significant tumor recurrence or metastasis as assessed by imaging; * (4) age 18 years - 75 years; * (5) ecog score of 0 or 1; * (6) laboratory tests tolerant to chemotherapy; * (7) hematological examination: no obvious signs of hematologic diseases, anc ≥ 1.5 × 10\^9/l, platelet count ≥ 80 × 10\^9/l, hb ≥ 90 g/l, wbc ≥ 3.0 × 10\^9/l before enrollment, and no bleeding tendency; (8) biochemical examination: total bilirubin \< 1.5 times the upper limit of normal value, ast, alt \< 2.5 times the upper limit of normal value, creatinine \< 1.5 times the upper limit of normal value. exclusion criteria: * (1) other pathological types of tumors; * (2) pregnant or nursing women; * (3) those with a history of other malignant neoplastic disease in the last 5 years; * (4) those with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder, where the investigator determines whether the clinical severity prevents signing an informed consent form or affects the patient's compliance with oral medications; * (5) clinically severe (i.e., active) heart disease, such as symptomatic coronary artery disease, new york heart association (nyha) class ii or worse congestive heart failure or arrhythmias requiring pharmacologic intervention, or a history of myocardial infarction within the last 12 months; * (6) severe diabetes-related complications, such as diabetic nephropathy, diabetic ketosis, etc; * (7) those with digestive tract obstruction or physiological abnormalities, or suffering from malabsorption syndrome, which may affect s-1 absorption; * (8) those who have had gastrointestinal bleeding in the last two weeks, or are at high risk of bleeding as judged by the investigator; * (9) known to have peripheral nerve disease ≥ nci-ctc ae grade 1. but with deep tendon reflexes (dtr) only; * (10) those requiring immunosuppressive therapy for organ transplantation; * (11) who have received other chemotherapy regimens * (12) those with uncontrolled severe infections, or other serious concomitant diseases; * (13) allergic to s-1 or any of the study drug components.
clinical evaluation of fenestration decompression combined with secondary curettage for ameloblastoma of the jaw: retrospective radiographic analysis

Conditions: Cystic Cavity Area Reduction Efficiency; the Recurrence of the Tumor

Summary: objectives: to investigate the outcomes of fenestration decompression combined with secondary curettage (fdsc) in the surgical treatment of jaw ameloblastoma. methods: medical records of patients diagnosed as multicystic ameloblastoma (ma) or unicystic ameloblastoma (ua) by routine pathology were collected from january 2010 to december 2017 in ninth people's hospital, shanghai jiaotong university medical college. patients were divided into two groups based on the management regimen: fdsc group, and local curettage (lc) group. patients were followed up for 3-8 years, using panoramic radiography to measure the change of the area of the cystic cavity involved in ameloblastoma and the recurrence or malignant transformation of the tumor in both groups. a total of 233 eligible patients were selected for provisional screening, including 145 patients with ma, and 88 patients with ua.


Eligibility criteria:
inclusion criteria: -medical records of patients who were diagnosed with multicystic ameloblastoma (ma) or unicystic ameloblastoma (ua) by routine pathology were collected from january 2010 to december 2017 in ninth people's hospital of shanghai jiaotong university medical college. exclusion criteria: * followed up less than 3 years * for fdsc group, fenestration decompression failed * recurrent ameloblastoma * received other type of surgery;
comparison of a non-invasive central venous pressure device and physical examination in patients with chronic kidney disease

Conditions: Central Venous Pressure

Summary: the primary objective of this study is to determine whether a correlation exists between the mespere non-invasive central venous pressure (nicvp) device for measuring central venous pressure (cvp), and assessment of cvp via physical examination.

the estimation of central venous pressure (cvp) is part of routine clinical examination. central venous pressure is the indication of the pressure in the right atrium of the heart and it can be measured by determining the height of the blood column in the internal or external jugular vein. clinical use of cvp has a wide range of applications including diagnosis of heart failure, pleural effusion, hypervolemia, hypovolemia, and sepsis. the standard clinical method for attaining cvp non-invasively is the physical examination of jugular venous pulse (jvp). the jvp provides a useful estimate of the cvp. it is often difficult to identify the internal jugular vein to determine the jvp. the internal jugular vein is deep and adjacent to the carotid artery and pulsations derived from the artery may obscure the subtle venous pulsations. manoeuvres to differentiate carotid pulsation and jugular pulsation are helpful in identifying the internal jugular vein, however determining the jvp based on the internal jugular vein examination is difficult. examination of the external jugular vein to determine jvp is an appealing alternative. the external jugular vein is easier to visualize and studies have demonstrated that this is a reliable method that correlates highly with catheter measured cvp.

Eligibility criteria:
inclusion criteria: * age 18 years or older at the time of enrolment * chronic kidney disease patients and healthy volunteers * participants should be able to provide written informed consent * subject is termed eligible as determined by pre-screening phase (as defined in protocol) exclusion criteria: * unable to identify external jugular vein (ejv) * unable to identify internal jugular vein (ijv) * unable to access right side of subject's neck * allergic to adhesive tape * history of central vein stenosis * undergoing photodynamic therapy (pdt) * presence of an arteriovenous fistula

Keywords: central venous pressure kidney diseases chronic kidney disease healthy subjects non-invasive monitor
intravitreal ranibizumab injection as adjuvant in the treatment of postvitrectomy diabetic vitreous hemorrhage accompanied by neovascular glaucoma

Conditions: Diabetic Retinopathy; Glaucoma, Neovascular

Summary: to determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the treatment of postvitrectomy diabetic vitreous hemorrhage (pdvh) accompanied by neovascular glaucoma (nvg) as a means of preventing recurrent vitreous hemorrhage （vh） and optimizing postoperative intraocular pressure（iop）control.


Eligibility criteria:
inclusion criteria: * age≥18 years * pdvh obscuring the disc and vessels for more than 14 days and no evidence of retinal detachment after primary vitrectomy for pdr-related complications such as nonclearing vh, macula-involving or macula-threatening tractional retinal detachment, or fibrovascular proliferation with vitreoretinal adhesions * nvg occurred following pdvh less than 4 weeks (nvg was diagnosed when an iop elevation of 22mmhg or more was accompanied by neovascularization of the iris and/or the anterior chamber angle) exclusion criteria: * intraoperative use of long-acting gas or silicone oil in primary vitrectomy, repeat vitrectomy after primary vitrectomy for retinal diseases other than vh, previous history of vitrectomy * previous intravitreal injection of ranibizumab or bevacizumab in either eye * previous intravitreal corticosteroids injection in either eye * pregnancy or current oral contraceptive intake * usage of clopidogrel bisulfate or coumadin * uncontrolled hypertension and cardiac disease * uncontrolled renal or liver disease
ordered eating and acute exercise

Conditions: Glucose Metabolism Disorders; Hunger

Summary: there is well documented evidence that ingesting dietary carbohydrate in large amounts tends to increase postprandial glucose. in healthy populations, this is not necessarily a problem, but continuous exposure to high levels of glucose-hyperglycemia-is a defining characteristic and risk factor for type 2 diabetes mellitus. consuming a carbohydrate-rich food as the final food in a meal sequence has been shown to significantly reduce postprandial glucose excursions in both diabetes patients and in healthy controls. the exact mechanisms behind this phenomenon are not well understood, but one proposed course is simply that the vegetable and protein already being digested slows the rate of glucose rise. despite the findings, little-to-no research has examined how manipulating the order of foods in a meal impacts subsequent exercise responses. in this experimental crossover study, each participant will undergo two acute feeding conditions (carbohydrate-rich foods first vs. last in a meal), which will be followed by exercise 60 minutes later. we will observe the effects of meal order on postprandial glucose, substrate/fuel utilization, and subjective perceptions at rest and during 30 minutes of exercise.


Eligibility criteria:
inclusion criteria: * currently physically active (scheduled exercise at least three days per week for 30 minutes each time over the last three months) * ability to perform moderate-to-high intensity running for at least 30 minutes exclusion criteria: * any allergy or other condition that would prohibit the consumption of poultry, rice, or broccoli * any injury or disease (cardiovascular disease, diabetes, pulmonary disease except controlled asthma) precluding physical exercise * currently pregnant * implanted electrical devices such as a pacemaker.

Keywords: exercise glucose fat metabolism hunger
study evaluating long-term safety of desvenlafaxine succinate sustained release with japanese adult subjects in major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of japanese subjects with major depressive disorder (mdd). the secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.


Eligibility criteria:
inclusion criteria: * outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (mdd), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study. exclusion criteria: * clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ecg), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of mdd.

Keywords: open-label long-term extension study
a study of vet3-tgi in patients with solid tumors

Conditions: Solid Tumor, Adult; Microsatellite Stable Colorectal Cancer; Head and Neck Squamous Cell Carcinoma; Cervical Cancer; Kidney Cancer; Renal Cell Carcinoma; Melanoma Stage IV; Merkel Cell Carcinoma of Skin; Mesothelioma; Non-small Cell Lung Cancer

Summary: vet3-tgi is an oncolytic immunotherapy designed to treat advanced cancers. vet3-tgi has not been given to human patients yet, and the current study is designed to find a safe and effective dose of vet3-tgi when administered by direct injection into tumor(s) (called an intratumoral injection) or when given intravenously (into the vein) both alone and in combination with pembrolizumab in patients with solid tumors (stealth-001).

vet3-tgi was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone. this is a phase 1 dose escalation (and expansion) study with vet3-tgi administered by direct injection into tumor(s) or by intravenous infusion. the dose escalation has 4 groups: the first group (group a) will determine the highest tolerated dose of vet3-tgi when injected into tumor(s); the second group (group c) will determine the highest tolerated dose of vet3-tgi when infused into the vein. the third and fourth groups (group b and d) will combine vet3-tgi with pembrolizumab. these groups will begin at the highest tolerated dose determined in group b and group d, respectively. once the highest tolerated dose is found for each of these groups, that dose may be expanded to up to 15 additional patients to better examine the efficacy of vet3-tgi.

Eligibility criteria:
key inclusion criteria: * have pathologically confirmed, advanced, unresectable, or metastatic solid tumors. preferred indications include, but are not limited to, breast carcinoma, bladder carcinoma, cervical squamous carcinoma, colorectal carcinoma, esophageal carcinoma, head and neck squamous carcinoma, renal cell carcinoma, ovarian carcinoma, sarcoma, thymoma, and uterine carcinoma. * failed, intolerant to, or refused potentially curative treatment options, including but not limited to, standard of care molecularly targeted agents, immunotherapy (e.g., anti -pembrolizumab/pdl1 antibodies), and chemotherapy * measurable disease as per recist 1.1 criteria * at least one tumor amenable to safe itu injections and/or biopsies * ecog performance status 0 or 1 * demonstrate adequate organ function * must be willing to comply with all protocol procedures and adhere to post-treatment care instructions additional inclusion criteria exist key exclusion criteria: * prior systemic therapy washout (dependent upon the therapy) * requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections. * cns metastases and/or carcinomatous meningitis that have not been completely resected or completely irradiated. * prior history of myocarditis * known hiv/aids, active hbv or hcv infection. * receiving high dose immunosuppressive medication or has a significant immunodeficiency (e.g. transplant recipient, etc). additional exclusion criteria exist
safety and dose finding study of dtx101 (aavrh10fix) in adults with moderate/severe to severe hemophilia b

Conditions: Hemophilia B

Summary: a phase 1/2, open-label, dose-finding safety study of single ascending doses of dtx101 in adult males with moderate/severe to severe hemophilia b.

hemophilia b is an x-linked recessive genetic bleeding disorder caused by mutations in the factor ix (fix) gene. fix is produced in the liver and is critical for fibrin clot formation. hemophilia b is characterized by frequent, spontaneous internal bleeding that can lead to chronic arthropathy (joint damage), intracranial hemorrhage, and even death. in patients with moderate/severe to severe hemophilia b, the majority of bleeding episodes occur in the joints and, if not treated, lead to debilitating damage and a decreased quality of life. this study will evaluate the safety and efficacy of the adeno-associated virus (aav) to deliver human factor ix (hfix) gene, the healthy gene necessary to make fix, to the liver where fix is normally produced. this study will determine if aavrh10 can produce clinically meaningful fix levels in patients with moderately/severe or severe hemophilia b. this study was previously posted by dimension therapeutics, which has been acquired by ultragenyx in november 2017.

Eligibility criteria:
inclusion criteria: 1. male ≥ 18 years of age. 2. moderate/severe or severe hemophilia b (baseline fix activity ≤ 2% of normal or documented history of fix activity ≤2%). 3. at least 3 bleeding episodes per year that require on-demand treatment with fix or are treated with a prophylactic regimen of fix. 4. at least 100 days exposure history to fix. 5. no documented history of inhibitors (neutralizing antibodies) to exogenous fix. 6. no known allergic reaction to exogenous fix or any component of dtx101. 7. willing to stop prophylactic treatment with recombinant fix at specified time points during the study. exclusion criteria: 1. history of significant liver disease (ie, portal hypertension). 2. significant hepatic inflammation or cirrhosis. 3. evidence of active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection. 4. history of human immunodeficiency virus (hiv) infection and any of the following: cd4+ cell count \ 200 copies/ml, on 2 separate occasions, as measured by polymerase chain reaction. 5. anti-aavrh10 neutralizing antibody titer \> 1:5. 6. participation (current or previous) in another gene therapy study. 7. participation in another investigational medicine study within 3 months before screening. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: gene therapy hemophilia b
the addition of montelukast to fluticasone in the treatment of perennial allergic rhinitis

Conditions: Rhinitis, Allergic, Perennial

Summary: some people with nasal allergy symptoms continue to have symptoms even after treatment with a nasal steroid spray. the purpose of this study is to see if these patients are helped by adding another medication (montelukast) to their treatment compared to placebo (a substance that looks like the active medication but does not contain the drug).

clinicians frequently prescribe an oral h1 antihistamine for allergic rhinitis patients with residual symptoms after taking an intranasal steroid. surprisingly, the only studies investigating this combination of drugs have failed to show added efficacy of the h1 receptor over the intranasal steroids alone. adding montelukast, a leukotriene receptor antagonist, to an intranasal steroid has not been studied in a placebo controlled fashion. wilson and colleagues, in an open study of patients with chronic rhinosinusitis, showed a benefit of adding montelukast. the investigators would like to recruit perennially allergic subjects and place them on fluticasone for 2 weeks. those subjects with residual symptoms would then be randomized to receive either placebo or montelukast in addition to continuing the fluticasone for an additional 2 weeks. a positive study would support clinical practice and would serve as a preemptive strike against managed care plans that would not allow prescriptions for both drugs. hypothesis: the addition of montelukast to treatment of a perennially allergic subject with an intranasal steroid is more effective at relieving symptoms than a placebo.

Eligibility criteria:
inclusion criteria: * a clinical history of perennial allergic rhinitis and a positive skin prick test to dust mite, cockroach, mold, or cat or dog antigens. * willingness of the subject to participate in and complete the study, and the ability to understand the purpose of the trial. exclusion criteria: * physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. * women of childbearing potential who are pregnant, trying to become pregnant or nursing a child. * subjects treated with systemic steroids during the previous 30 days. * subjects treated with topical (inhaled, intranasal or intraocular) steroids, nasalcrom or opticrom during the previous 15 days. * subjects treated with oral antihistamines/decongestants during the previous seven days. * subjects treated with topical (intranasal or intraocular) antihistamines/decongestants during the previous 3 days. * subjects treated with immunotherapy who are escalating their dose. * subjects on chronic anti-asthma medications. * subjects with polyps in the nose or a significantly displaced septum. * subjects who have incurred an upper respiratory tract infection within 14 days of the start of the study.

Keywords: perennial allergic rhinitis